Details for New Drug Application (NDA): 208158
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NDA 208158 describes ALAWAY, which is a drug marketed by Bausch And Lomb and Bausch And Lomb Inc and is included in two NDAs. It is available from thirteen suppliers. Additional details are available on the ALAWAY profile page.
The generic ingredient in ALAWAY is ketotifen fumarate. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
The generic ingredient in ALAWAY is ketotifen fumarate. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 208158
| Tradename: | ALAWAY |
| Applicant: | Bausch And Lomb Inc |
| Ingredient: | ketotifen fumarate |
| Patents: | 0 |
Pharmacology for NDA: 208158
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 208158
Suppliers and Packaging for NDA: 208158
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALAWAY | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 208158 | ANDA | Bausch & Lomb Incorporated | 24208-600 | 24208-600-01 | 4 POUCH in 1 CARTON (24208-600-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL |
| ALAWAY | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 208158 | ANDA | Bausch & Lomb Incorporated | 24208-600 | 24208-600-99 | 12 POUCH in 1 CARTON (24208-600-99) / 1 VIAL in 1 POUCH / .4 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.025% BASE | ||||
| Approval Date: | Sep 24, 2020 | TE: | RLD: | No | |||||
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